Most devices categorized as Class III (devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury) are required to go through the full process of scientific and regulatory review under the Premarket Approval (PMA) pathway. To determine whether a device is Class III and what type of submission is required, sponsors may search the Product Classification Database for similar devices (for example, a Thermal Cerebral Blood Flow Diffusion Monitor is a Class III device, and sponsors should contact the Office of Device Evaluation to clarify the required submission type). If a similar device is already marketed, you may search the 510(k) or PMA databases either by device name or product code for information on how that similar device was submitted for premarket review. For example, classification product code LME produces a record for a Traditional 510(k) submission for a Cerebral Blood Flow Diffusion Monitor granted clearance in 1985 (K850657 in the 510(k) database). If the device is a new type not found in the Classification Database, it may be eligible for the De Novo process as a Class I or Class II device (the subject of a future post). PMAs have a few flavors, as well:

1. Traditional PMAs – where the sponsor submits all the required data modules in one package.
2. Modular PMAs – where a sponsor submits each required module for review once it has been completed.
3. Product Development Protocol (PDP) – where sponsors work out an agreement with the FDA on the device design and development activities, the outputs of these activities, and acceptance criteria for these outputs, and establishes reporting milestones to transmit important information to the FDA for review and response. Once approved, the sponsor may complete their PDP at their own pace, and a device with a completed PDP is considered to have an approved PMA.

Readers interested in more details on the PMA are encouraged to review the PMA website.

Text Copyright © 2019 Katrina Rogers